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What’s the Problem with Aortic Balloon Pumps for Non-Cardiac Surgery?
Datascope Corp./MAQUET is recalling 5,049 balloon pumps over alleged defects that could cause failure of the devices, resulting in adverse health complications, including death.
Datascope Models affected by the field correction action include CS100i, CS100, and CS300, which were manufactured from July 1, 2003 to June 16, 2017.
The recall also applies to any System 98 or System 98XT IABP that was converted to a CS100i or CS300 IABP, according to the FDA Safety Alert .
Datascope Balloon Pumps are cardiac devices used to assist cardiac surgery patients, and to treat patients with acute coronary syndrome (ACS) or complications from heart failure.
The recall was issued over concerns that if a patient requires circulatory support with an intra aortic balloon pump and the device does not work, or if therapy is stopped during use without a replacement IABP available, device failure may result in immediate and serious adverse health consequences, including death.
At least one patient death due to a false blood detection alarm has been reported. Patients receiving IABP therapy are in critical condition and sudden interruption of therapy could result in failure to initiate therapy.
Getinge/Maquet said it was developing new software to address the issue around February 2019. However, that does not take away from the potential for injury to patients; or the harm to families of patients who may have died from cardiovascular complications the device was responsible for.
Related article: Intra-Aortic Balloon Pump Catheter Recall Lawsuit
FDA Expands Class I Recall
The FDA expanded the recall and designated it as “Class 1,” which is the highest level of recall the agency can issue. The expanded recall involves all lots manufactured before June 30, 2013, including units distributed in the U.S. from March 24, 2003 to December 11, 2013.
How Do IABPs Work for Patients Undergoing Cardiac Surgery?
Intra-Aortic Balloon Pumps (IABPs) are mechanical devices that help the heart pump blood. The devices use a balloon that inflates and deflates in time with heartbeats. IABPs are used in patients undergoing cardiac and non-cardiac surgery, as well as patients who have had a severe heart attack or heart failure.
Cardiosave Intra-Aortic Balloon Pump Recall
In May 2018, the U.S. Food and Drug Administration issued a recall for nearly 3,000 CARDIOSAVE hybrid IABPs manufactured by Maquet Datascope Corp.
The problem is that a design flaw could allow fluid (such as saline) to get inside the aortic balloon pump. The fluid can cause corrosion, short-circuiting, power failure, and device shut-down. Patients may need to be resuscitated, or suffer severe injury or death:
“The fluid can cause corrosion of internal components such as the electronic circuit boards, and lead to device malfunction (e.g., sudden stops) which can cause a delay or interruption in therapy," FDA said. "Device failure may result in immediate and serious adverse health consequences, including death.”
Contact us today to speak to experienced defective medical devices attorneys to learn more about your legal rights.
Get a Free Datascope Intra-Aortic Balloon Pump Lawsuit Evaluation With Our Lawyers
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Datascope Intra-Aortic Balloon Pump Lawsuits. Our law firm is handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Case Evaluation: Again, if you or a loved one was injured, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.